26 February 2021
This was a targeted letter sent to specific organisations that the MHRA knows have these devices. It was sent on Wednesday 17 February 2021 and is being published here for information.
I am writing to you concerning the purchase and use of the following implants and associated surgical instruments manufactured by Implants International Ltd., trading as Xtremity Solutions Ltd:
Roto-Glide Great Toe MTP implant system
Footlocker midfoot & forefoot plate & screw implants
Omni-Fix Intramedullary (IM) nail system
These products have not had valid CE certification since 04 September 2019 and therefore any devices manufactured and/or distributed after that date should not be used in the UK. They should be returned to the manufacturer.